Establish an Effective Change Management Process for Stability Studies


Instructor: Kim Huynh-Ba
Product ID: 704085

  • Duration: 2 hrs
Upon completion of this training program, attendees will learn key elements of a change management process, identify key indicators of change and learn the regulatory requirements for change control. This session will also discuss different observations due to the lack of effective change control program.
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Why Should You Attend:

Stability is defined as a critical quality attribute (CQA) in the drug development process as it determines the shelf life of a pharmaceutical product; however, change is an inherent part of the product life cycle. Change can be made as an addition, deletion or modification of process, materials, product, procedures, equipment, and these changes may result to adding, canceling, amending or modifying current stability studies. Therefore, an effective change management process is necessary to monitor the stability profile of the product. This session will review the current regulatory requirements such as FDA, ICH, GMP regulations on change control program, discuss a systematic process to evaluate these changes and the types of changes may affect stability studies.

Areas Covered in the Webinar:

  • Purpose of stability studies
  • Understand the change management process.
  • Establish necessary documentation to support making changes.
  • Understand various changes exist in the product life cycle.
  • Classify changes to determine appropriate strategies.
  • Distinguish between minor and major changes of a registration stability program.
  • Understand potential risks to manage these changes to your stability studies.

Who Will Benefit:

  • Quality control managers and personnel
  • Pharmaceutical scientists
  • Manufacturers of raw material and ingredients
  • QC analysts and lab managers
  • QA managers and personnel
  • Regulatory affairs professional
  • Compliance scientists
Instructor Profile:
Kim Huynh-Ba

Kim Huynh-Ba
Founder and Technical Director, Pharmalytik

Kim Huynh-Ba has over 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She is currently the executive director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Her clients are from various sizes of pharmaceutical companies in US and abroad. In 2011-2013, she took a sabbatical from Pharmalytik to join the USP Convention as the Director of Pharmacopeial Education Department, where she was responsible for their education programs worldwide.

Ms. Huynh-Ba has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. She is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an adjunct professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses.

She is a member of the Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 president. Ms. Huynh-Ba was recently elected as a member of the USP Council of Experts for the 2015-2020 cycle and Chair the Chemical Medicines IV Expert Committee. She is also the Chair of USP Good Documentation Practices Expert Panel and a member of USP Impurities of Drug Products Expert Panel.

Ms. Huynh-Ba has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality areas. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010).

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